Diprivan
Diprivan® (Propofol) Injectable Emulsion, USP
Approved
Approval ID
ee0c3437-614d-4631-a061-257f5f60c70b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROPOFOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-269
Application NumberNDA019627
Product Classification
M
Marketing Category
C73594
G
Generic Name
PROPOFOL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (6)
SOYBEAN OILInactive
Quantity: 100 mg in 1 mL
Code: 241ATL177A
Classification: IACT
PROPOFOLActive
Quantity: 10 mg in 1 mL
Code: YI7VU623SF
Classification: ACTIB
EGG PHOSPHOLIPIDSInactive
Quantity: 12 mg in 1 mL
Code: 1Z74184RGV
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
GLYCERINInactive
Quantity: 22.5 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT